Doctoral Dissertation Research in Economics: The Effect of Deregulation on the Cost, Availability, and Quality of Health Care

美国食品和药物管理局（FDA）对各种各样的保健产品进行监管，以确保它们在出售给消费者之前的安全性和有效性。虽然这些法规旨在保护消费者，但它们也不可避免地增加了企业将新医疗技术推向市场的成本和时间。这些障碍可能会让消费者选择的产品更少，甚至推迟他们获得可能挽救生命的医疗技术的机会。没有新进入者的威胁，现有的公司可以收取更高的价格，因为他们知道消费者几乎没有其他选择。以医疗器械为重点，作者提出了一个问题，即放宽FDA的监管是否可以提高医疗保健的质量和可及性，并应对不断上涨的成本。该项目将数百万医疗产品的新数据与统计分析相结合，以了解放松管制如何影响医疗设备市场中的竞争、价格、数量和质量。具体而言，作者将研究2015年FDA放松管制事件，该事件解除了对某些医疗器械的管制，但没有对其他医疗器械进行管制。这项研究的结果对于决策者来说是有价值的，他们试图做出明智的决定，如何平衡产品监管的好处和它强加给公司和消费者的成本。受美国食品和药物管理局（FDA）监管的产品占美国人支出的每1美元的20美分（食品和药物管理局，2021年）。一方面，这些法规——通常采取上市前批准程序的形式——旨在确保消费品的安全性和有效性。另一方面，上市前的批准可能会给制造商带来巨大的成本，这阻碍了企业进入，甚至可能降低产品安全性（Rogers, 2022）。本项目考虑FDA法规如何与市场力量相互作用，以及对医疗设备这一重要部门的产品成本和质量产生的影响。作者将市场进入、设备交易和保险索赔的详细数据与计量经济学方法结合起来回答这个问题。他们利用了2015年FDA放松管制事件，该事件取消了250种医疗器械类型的上市前测试，作为“自然实验”，并使用差异中的差异和事件研究技术来比较放松管制与未受影响的设备类型的影响。他们首先使用FDA的注册数据来评估对市场结构的影响，比如销售这些设备的公司的数量和类型。接下来，他们使用医疗保健提供商购买的数百万医疗设备的细粒度数据来研究对购买设备的价格和数量的影响。最后，他们使用保险公司的索赔，并考虑使用这些设备的程序的价格、数量和质量是否会发生变化。该项目的研究结果将使政策制定者更好地了解监管如何与市场力量相互作用，并在一个重要行业的整个供应链中产生连锁反应。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The U.S. Food and Drug Administration (FDA) regulates a wide array of health care products to ensure their safety and efficacy before they can be sold to consumers. While these regulations are intended to protect consumers, they also inevitably make it more expensive and time-intensive for companies to bring new medical technology to the market. These hurdles could leave consumers with fewer products to choose from or even delay their access to potentially life-saving medical technology. Without the threat of new entrants, existing firms are able to charge higher prices, knowing that consumers have few alternatives. Focusing on medical devices, the author(s) asks whether relaxing FDA regulation could increase the quality and accessibility of health care and combat rising costs. This project combines new data on millions of medical products with statistical analysis to understand how deregulation affects competition, prices, quantity, and quality in the market for medical devices. Specifically, the author(s) will study an FDA deregulation event in 2015 that deregulated some medical devices but not others. The results of this study will be valuable for policymakers who seek to make informed decisions about how to balance the benefits of product regulation against the costs it imposes on firms and consumers.Products regulated by the U.S. Food and Drug Administration (FDA) account for 20 cents out of every dollar Americans spend (Food and Drug Administration, 2021). On the one hand, these regulations — which often take the form of pre-market approval processes — aim to ensure the safety and efficacy of consumer products. On the other hand, pre-market approvals can impose substantial costs on manufacturers, which prevent firm entry and can even reduce product safety (Rogers, 2022). This project considers how FDA regulation interacts with market forces and the resulting effect on the cost and quality of products in an important sector: medical devices. The author(s) bring together detailed data on market entry, device transactions, and insurance claims with econometric methods to answer this question. They exploit a 2015 FDA deregulation event that removed pre-market testing for 250 medical device types as a “natural experiment” and use difference-in-difference and event study techniques to compare the effects on deregulated versus unaffected device types. They first use FDA registration data to assess the effects on market structure, like the number and types of firms that sell these devices. Next, they use fine-grained data on millions of medical device purchases made by healthcare providers to study the effects on prices and quantities of devices purchased. Finally, they use insurer claims and consider whether the prices, quantity, and quality of procedures that use these devices change. The project’s findings will provide policymakers with a better understanding of how regulation interacts with market forces and causes ripple effects throughout the supply chain in an important industry.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.